The patient`s 4Kscore Test result is 27% - OPKO Lab
Transcription
The patient`s 4Kscore Test result is 27% - OPKO Lab
Clinician Information Physician Name Physician Group Physician Address City, State Zip Phone: Fax: Patient Information Name: John Doe Gender: M Chart No: 00000000 DOB:04/30/1949 Accession #: FKS-000001 Collected:03/16/2015 Received:03/17/2015 FINAL REPORT Clinical & Specimen Information Prior Biopsy: No Age:65 DRE:Neg. Received: Whole blood in K2EDTA Total PSA and Free PSA Results Total PSA: 7.5 F/T PSA Ratio: 21% (Reference Range 0.0 – 4.0 ng/mL) (Reference Range > 25%) 4Kscore Test Result & Interpretation The patient’s 4Kscore Test result is 27% At a 4Kscore Test result of 27%, about 1 in 4 men biopsied would have high-grade prostate cancer. 4Kscore Test Result ≤1% 5% 10% 15% 20% 25% 30% 40% ≥100 20 10 6.7 5 4 3.3 2.5 50% 60% 70% 80% 90%≥ 95% 2 <2 Number of men to biopsy to find one high-grade prostate cancer The 4Kscore Test result is a personal risk of a high-grade prostate cancer of Gleason score 7 or higher on prostate biopsy. Other clinical information along with the 4Kscore Test result should be considered in the discussion between the urologist and the patient in the process of making the most informed decision about undergoing biopsy. Test Description: The 4Kscore Test was developed by OPKO Lab and is performed by OPKO Lab at its CLIA-accredited laboratory. The 4Kscore Test is calculated from the results of four in-vitro diagnostic immunoassays: Total PSA, Free PSA, Intact PSA, and Human Kallikrein (hK2), plus patient age, reported DRE result, and history of prior biopsy. The 4Kscore Test result is reported as a probability of high-grade cancer with a range of less than 1% to greater than 95%. Additional Comments: None Report Date: 03/18/2015 Signature: Vinita Mathur, M.D. Report Time: 12:00 PM The 4Kscore test was developed and its performance characteristics determined by OPKO Lab. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is accredited to perform high-complexity clinical testing. The test has not been approved by the U.S. Food and Drug Administration. This test is used for clinical purposes. These results are adjunctive to the ordering physician’s evaluation and clinical judgment. OPKO’s Medical Affairs Team of Board Certified Urologists is available to provide additional information to physicians regarding the 4Kscore Test results. They can be reached at 1-877-922-8364 or by email at [email protected]. Information provided by our Medical Affairs Team does not constitute medical advice or a medical opinion and should not be construed as a recommendation for a particular course of treatment for a patient or substitute for a patient’s physician’s independent professional medical opinion. OPKO Lab • 1450 Elm Hill Pike, Nashville TN 37210 • www.opkolab.com Toll Free: (888) 868-7522 • Office: (615) 874-0410 • Fax: (615) 467-6707 Lab Director: Vinita Mathur, M.D. • CLIA: 44D0949538 Page 1 of 2 a Division of OPKO Health, Inc. Patient Counseling Report Based on your 4Kscore Test result, your probability for having a high-grade cancer is 27%. This means that if 100 men with your same 4Kscore Test result were to have a prostate biopsy, 27 out of the 100 men would have a finding of high-grade prostate cancer upon biopsy. 73% chance that = the biopsy does not find a high-grade prostate cancer. 27% chance that = the biopsy finds a high-grade prostate cancer. OPKO Lab • 1450 Elm Hill Pike, Nashville TN 37210 • www.opkolab.com Toll Free: (888) 868-7522 • Office: (615) 874-0410 • Fax: (615) 467-6707 Lab Director: Vinita Mathur, M.D. • CLIA: 44D0949538 Page 2 of 2 70024 (03/18/15) a Division of OPKO Health, Inc.